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WO2009143168A3 - Vaccine assays - Google Patents

Vaccine assays Download PDF

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Publication number
WO2009143168A3
WO2009143168A3 PCT/US2009/044539 US2009044539W WO2009143168A3 WO 2009143168 A3 WO2009143168 A3 WO 2009143168A3 US 2009044539 W US2009044539 W US 2009044539W WO 2009143168 A3 WO2009143168 A3 WO 2009143168A3
Authority
WO
WIPO (PCT)
Prior art keywords
efficacy
component
vaccine
pathogen
assays
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2009/044539
Other languages
French (fr)
Other versions
WO2009143168A2 (en
Inventor
John Donnelly
Ping Wu
George Santos
Marzia Monica Giuliani
William Andrews
Jie Chen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Novartis AG
Original Assignee
Novartis AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novartis AG filed Critical Novartis AG
Priority to EP09751396A priority Critical patent/EP2297578A2/en
Publication of WO2009143168A2 publication Critical patent/WO2009143168A2/en
Publication of WO2009143168A3 publication Critical patent/WO2009143168A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/569—Immunoassay; Biospecific binding assay; Materials therefor for microorganisms, e.g. protozoa, bacteria, viruses
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/205—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Campylobacter (G)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/22—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Neisseriaceae (F), e.g. Acinetobacter
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/24—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
    • G01N2333/245—Escherichia (G)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/285—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Pasteurellaceae (F), e.g. Haemophilus influenza
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/305—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Micrococcaceae (F)
    • G01N2333/31—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Micrococcaceae (F) from Staphylococcus (G)
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/195—Assays involving biological materials from specific organisms or of a specific nature from bacteria
    • G01N2333/315—Assays involving biological materials from specific organisms or of a specific nature from bacteria from Streptococcus (G), e.g. Enterococci

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Food Science & Technology (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Biotechnology (AREA)
  • Medicinal Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Virology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)

Abstract

The present invention is directed to methods, assays and compositions for implementing such methods and assays for assessing efficacy of individual components in multi-component vaccines and for assessing efficacy of a vaccine against a pathogen. In one aspect, the method of assessing efficacy of a vaccine against a pathogen is a quick assay that tests for an activity correlated with efficacy such as binding in an ELISA rather than requiring the time and expense of an assay that detects actual bactericidal activity. In another aspect, the method for testing the efficacy of an individual component in a multi-component vaccine includes obtaining an immune sample from a subject inoculated with the multi-component vaccine; blocking the portion of the immune sample that recognizes the individual component such as by addition of the individual component, and testing the efficacy of the immune sample to respond to the pathogen.
PCT/US2009/044539 2008-05-19 2009-05-19 Vaccine assays Ceased WO2009143168A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP09751396A EP2297578A2 (en) 2008-05-19 2009-05-19 Vaccine assays

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US5443908P 2008-05-19 2008-05-19
US61/054,439 2008-05-19

Publications (2)

Publication Number Publication Date
WO2009143168A2 WO2009143168A2 (en) 2009-11-26
WO2009143168A3 true WO2009143168A3 (en) 2010-01-21

Family

ID=41037846

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2009/044539 Ceased WO2009143168A2 (en) 2008-05-19 2009-05-19 Vaccine assays

Country Status (3)

Country Link
US (1) US20100035234A1 (en)
EP (1) EP2297578A2 (en)
WO (1) WO2009143168A2 (en)

Families Citing this family (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX339524B (en) 2001-10-11 2016-05-30 Wyeth Corp Novel immunogenic compositions for the prevention and treatment of meningococcal disease.
GB0408977D0 (en) * 2004-04-22 2004-05-26 Chiron Srl Immunising against meningococcal serogroup Y using proteins
EP2589391B1 (en) * 2010-07-01 2018-11-14 Rosetta Exosome Co., Ltd. Bacterial cell-derived microvesicles for use in a method of treating cancer
US8956859B1 (en) 2010-08-13 2015-02-17 Aviex Technologies Llc Compositions and methods for determining successful immunization by one or more vaccines
HUE034544T2 (en) 2010-08-23 2018-02-28 Wyeth Llc STABLE FORMULATIONS OF NEISSERIA MENINGITIDIS rLP2086 ANTIGENS
JP5976652B2 (en) 2010-09-10 2016-08-24 ワイス・エルエルシー Non-lipidated variant of Neisseria meningitidis ORF2086 antigen
WO2013132040A2 (en) 2012-03-08 2013-09-12 Novartis Ag In vitro potency assay for protein-based meningococcal vaccines
KR101784644B1 (en) 2012-03-09 2017-10-11 화이자 인코포레이티드 Neisseria meningitidis compositions and methods thereof
SA115360586B1 (en) 2012-03-09 2017-04-12 فايزر انك Neisseria meningitidis compositions and methods thereof
RU2644340C2 (en) * 2012-06-14 2018-02-08 Новартис Аг Vaccines for serogroup x meningococcus
EP2964665B1 (en) 2013-03-08 2018-08-01 Pfizer Inc Immunogenic fusion polypeptides
CN105492021B (en) 2013-09-08 2018-12-04 辉瑞公司 Neisseria meningitidis composition and its method
CN107249626A (en) 2015-02-19 2017-10-13 辉瑞大药厂 Neisseria meningitidis compositions and methods thereof
EP3577130A2 (en) 2017-01-31 2019-12-11 Pfizer Inc Neisseria meningitidis compositions and methods thereof
US20220178915A1 (en) * 2019-03-25 2022-06-09 Sekisui Medical Co., Ltd. Immunoassay method and detection kit for respiratory tract virus
US20220221451A1 (en) * 2019-03-25 2022-07-14 Sekisui Medical Co., Ltd. Immunochromatographic assay method and test strip for use in said method
JPWO2020196296A1 (en) * 2019-03-25 2020-10-01
CN115605222A (en) 2019-09-27 2023-01-13 辉瑞公司（Us） Neisseria meningitidis compositions and methods thereof
GB202115077D0 (en) * 2021-10-21 2021-12-08 Glaxosmithkline Biologicals Sa Assay
GB202115072D0 (en) * 2021-10-21 2021-12-08 Glaxosmithkline Biologicals Sa Assay

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000077518A2 (en) * 1999-06-11 2000-12-21 The Government Of The United States Of America, Represented By The Secretary, Department Of Healt H And Human Services Methods and compositions for opsonophagocytic assays
WO2003069342A1 (en) * 2002-02-11 2003-08-21 The Walter And Eliza Hall Institute Of Medical Research A method of screening
WO2005032583A2 (en) * 2003-10-02 2005-04-14 Chiron Srl Liquid vaccines for multiple meningococcal serogroups

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4525452A (en) * 1983-01-24 1985-06-25 Btc Diagnostics Limited Partnership Enzyme immunoassay with step of immersing sample in deionized water
MXPA00010722A (en) * 1998-05-01 2004-12-03 Chiron Corp Neisseria meningitidis antigens and compositions.
MXPA01010924A (en) * 1999-04-30 2002-05-06 Chiron Spa Conserved neisserial antigens.
GB0522765D0 (en) * 2005-11-08 2005-12-14 Chiron Srl Combination vaccine manufacture

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000077518A2 (en) * 1999-06-11 2000-12-21 The Government Of The United States Of America, Represented By The Secretary, Department Of Healt H And Human Services Methods and compositions for opsonophagocytic assays
WO2003069342A1 (en) * 2002-02-11 2003-08-21 The Walter And Eliza Hall Institute Of Medical Research A method of screening
WO2005032583A2 (en) * 2003-10-02 2005-04-14 Chiron Srl Liquid vaccines for multiple meningococcal serogroups

Non-Patent Citations (14)

* Cited by examiner, † Cited by third party
Title
FRASCH CARL E; BORROW RAY; DONNELLY JOHN: "Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease.", VACCINE 24 JUN 2009, vol. 27 Suppl 2, 21 May 2009 (2009-05-21), pages B112 - B116, XP002546594, ISSN: 1873-2518 *
GIULIANI MARZIA M; ET AL: "A universal vaccine for serogroup B meningococcus", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF USA, NATIONAL ACADEMY OF SCIENCE, WASHINGTON, DC, US, vol. 103, no. 29, 18 July 2006 (2006-07-18), pages 10834 - 10839, XP002450501, ISSN: 0027-8424 *
GRANOFF D M: "Assessing efficacy of Haemophilus influenzae type b combination vaccines.", CLINICAL INFECTIOUS DISEASES : AN OFFICIAL PUBLICATION OF THE INFECTIOUS DISEASES SOCIETY OF AMERICA 15 DEC 2001, vol. 33 Suppl 4, 15 December 2001 (2001-12-15), pages S278 - S287, XP002546587, ISSN: 1058-4838 *
GRANOFF DAN M; HARRIS SHANNON L: "Protective activity of group C anticapsular antibodies elicited in two-year-olds by an investigational quadrivalent Neisseria meningitidis-diphtheria toxoid conjugate vaccine.", THE PEDIATRIC INFECTIOUS DISEASE JOURNAL JUN 2004, vol. 23, no. 6, June 2004 (2004-06-01), pages 490 - 497, XP009122884, ISSN: 0891-3668 *
JODAR L; BUTLER J; CARLONE G; DAGAN R; GOLDBLATT D; KAYHTY H; KLUGMAN K; PLIKAYTIS B; SIBER G; KOHBERGER R; CHANG I; CHERIAN T: "Serological criteria for evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants", VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 21, no. 23, 4 July 2003 (2003-07-04), pages 3265 - 3272, XP004429737, ISSN: 0264-410X *
LI SHU; CHAN IVAN S F; MATTHEWS HOLLY; HEYSE JOSEPH F; CHAN CHRISTINA Y; KUTER BARBARA J; KAPLAN KAREN M; VESSEY S J RUPERT; SADOF: "Inverse relationship between six week postvaccination varicella antibody response to vaccine and likelihood of long term breakthrough infection.", THE PEDIATRIC INFECTIOUS DISEASE JOURNAL APR 2002, vol. 21, no. 4, April 2002 (2002-04-01), pages 337 - 342, XP009122885, ISSN: 0891-3668 *
MIURA KAZUTOYO; KEISTER DAVID B; MURATOVA OLGA V; SATTABONGKOT JETSUMON; LONG CAROLE A; SAUL ALLAN: "Transmission-blocking activity induced by malaria vaccine candidates Pfs25/Pvs25 is a direct and predictable function of antibody titer", MALARIA JOURNAL, BIOMED CENTRAL, LONDON, GB, vol. 6, no. 1, 8 August 2007 (2007-08-08), pages 107, XP021029741, ISSN: 1475-2875 *
QIN LI; GILBERT PETER B; COREY LAWRENCE; MCELRATH M JULIANA; SELF STEVEN G: "A framework for assessing immunological correlates of protection in vaccine trials.", THE JOURNAL OF INFECTIOUS DISEASES 1 NOV 2007, vol. 196, no. 9, 1 November 2007 (2007-11-01), pages 1304 - 1312, XP002546592, ISSN: 0022-1899 *
See also references of EP2297578A2 *
SHIN SUNG JAE; SHIN SEUNG WON; CHOI EUN JIN; LEE DEOG YONG; AHN JEONG MIN; YANG MOON SIK; JANG YONG SUK; YOO HAN SANG: "A predictive model for the level of sIgA based on IgG levels following the oral administration of antigens expressed in Saccharomyces cerevisiae.", JOURNAL OF VETERINARY SCIENCE DEC 2005, vol. 6, no. 4, December 2005 (2005-12-01), pages 305 - 309, XP002546591, ISSN: 1229-845X *
SPELLBERG BRAD; IBRAHIM ASHRAF S; LIN LIN; AVANESIAN VALENTINA; FU YUE; LIPKE PETER; OTOO HENRY; HO TIFFANY; EDWARDS JOHN E JR: "Antibody titer threshold predicts anti-candidal vaccine efficacy even though the mechanism of protection is induction of cell-mediated immunity.", THE JOURNAL OF INFECTIOUS DISEASES 1 APR 2008, vol. 197, no. 7, 1 April 2008 (2008-04-01), pages 967 - 971, XP002546593, ISSN: 0022-1899 *
STRADY C; JAUSSAUD R; BEGUINOT I; LIENARD M; STRADY A: "Predictive factors for the neutralizing antibody response following pre-exposure rabies immunization: validation of a new booster dose strategy", VACCINE, BUTTERWORTH SCIENTIFIC. GUILDFORD, GB, vol. 18, no. 24, 1 June 2000 (2000-06-01), pages 2661 - 2667, XP004196897, ISSN: 0264-410X *
WU J S; HWANG L Y; GOODMAN K J; BEASLEY R P: "Hepatitis B vaccination in high-risk infants: 10-year follow-up.", THE JOURNAL OF INFECTIOUS DISEASES JUN 1999, vol. 179, no. 6, June 1999 (1999-06-01), pages 1319 - 1325, XP002546586, ISSN: 0022-1899 *
ZELNIK V; HARLIN O; FEHLER F; KASPERS B; GÖBEL T W; NAIR V K; OSTERRIEDER N: "An enzyme-linked immunosorbent assay (ELISA) for detection of Marek's disease virus-specific antibodies and its application in an experimental vaccine trial.", JOURNAL OF VETERINARY MEDICINE. B, INFECTIOUS DISEASES AND VETERINARY PUBLIC HEALTH MAR 2004, vol. 51, no. 2, March 2004 (2004-03-01), pages 61 - 67, XP002546589, ISSN: 0931-1793 *

Also Published As

Publication number Publication date
WO2009143168A2 (en) 2009-11-26
US20100035234A1 (en) 2010-02-11
EP2297578A2 (en) 2011-03-23

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